[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616740":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":56,"collaborators":26,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":84,"overallStatus":88,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of New Brunswick","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mediterranean Diet Intervention","EXPERIMENTAL","Toddlers in this group will follow a Mediterranean-style diet for nine weeks. Families will receive Mediterranean diet foods for three weeks and take part in nine weekly sessions (one overview and eight follow-up sessions) focused on preparing toddler-appropriate Mediterranean meals. The sessions are designed to support consistency in feeding, track progress, and provide guidance on diet adherence. Measurements of toddler height, weight, body composition (BOD POD), stool samples, and questionnaires will be collected at baseline, 3 weeks, and 3 months post-baseline.",[13],"Behavioral: Mediterranean Diet Nutrition Program",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Diet","ACTIVE_COMPARATOR","Toddlers in this group will continue their usual diets for nine weeks while families participate in nine weekly general nutrition education sessions. Measurements of toddler height, weight, body composition (BODPOD), stool samples, and questionnaires will occur at the same time points as the intervention group. Families in this group will receive a $100 honorarium.",[19],"Behavioral: Standard Diet Education Program",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Mediterranean Diet Nutrition Program","A nine session nutrition and feeding program designed to assess how a Mediterranean-style diet influences toddler gut health, body composition, and inflammation. Toddlers will receive Mediterranean-style foods for the first three weeks, followed by continued guidance through bi-weekly educational sessions focused on meal preparation, food variety, and adherence. Specifically sessions will cover key topics such as toddler nutrient needs, budget-friendly meal planning, picky eating, family mealtime strategies, and mindful eating. The program emphasizes incorporating fruits, vegetables, legumes, whole grains, and healthy fats into toddler meals, reducing ultra-processed foods, and promoting balanced feeding during early childhood.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Diet Education Program","A nine session general toddler nutrition education program designed to reflect typical dietary patterns in Canadian families. Families receive sessions on topics such as feeding styles, cultural foods and feeding practices, understanding nutrition labels, food safety, choking hazards and prevention, healthy recipes, myths and misinformation, and meal structure and routines. No study foods are provided. Toddlers maintain their usual diets throughout the study while completing the same measurements as those in the intervention group.",[15],[32],{"name":33,"affiliation":5,"role":34},"Dr. Maryam Kebbe, PhD, CLC","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","15064516872","maryam.kebbe@unb.ca",[41],{"facility":5,"status":26,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Fredericton","New Brunswick","E3B 4J9","Canada","CA",{"type":48,"coordinates":49},"Point",[50,51],-66.66558,45.94541,{"lat":51,"lon":50},[54,55],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Maryam Kebbe","Associate Professor","100616740","mediterranean-diet-uptake-and-nutrition-on-child-health-inflammation-and-early-life-symbiosis-munchies-study-100616740",false,"NCT07309536","Mediterranean Diet Uptake and Nutrition on Child Health, Inflammation, and Early-life Symbiosis (MUNCHIES) Study","Mediterranean Diet Uptake and Nutrition on Child Health, Inflammation, and Early-life Symbiosis (MUNCHIES): A Randomized Controlled Trial","MUNCHIES","Inclusion Criteria:\n\n* Parent is ≥19 years of age.\n* Carried a singleton pregnancy.\n* Delivered at term (≥37 weeks gestation).\n* Delivered vaginally or by cesarean section.\n* Infant was born with a birth weight between 2,500 g and 4,500 g.\n* Toddler is between 24 and 36 months of age at enrollment.\n* Parent is able to communicate in English.\n* Parent is willing to adhere to the Mediterranean diet for their toddler for 3 weeks.\n* Parent is willing to participate in a nutrition education program for 3 months.\n* Parent is willing to complete all measurements and provide a stool sample from their toddler.\n\nExclusion Criteria:\n\n* Toddler has food allergies or dietary restrictions (e.g., gluten-free) that make it difficult to follow a Mediterranean diet.\n* Toddler is at high risk for food allergies (e.g., strong family history of multiple food allergies common to the Mediterranean diet).\n* Toddler is already following a Mediterranean diet.\n* Toddler has had recent or active consumption of antibiotics, probiotics, or prebiotic drops.\n* Toddler has an active acute illness, such as fever, diarrhea, or constipation.\n* Toddler was born with a congenital illness or malformation that could affect diet, inflammation, gut health, or body composition.\n* Toddler is currently breastfeeding, formula-feeding, or combination feeding.",true,"ALL","24 Months","36 Months",{"count":72,"type":73},40,"ESTIMATED","INTERVENTIONAL",[76],"NA","Toddlerhood (ages 2-3) is a critical window when the gut microbiome is still developing and eating habits are being established. Yet, many Canadian toddlers eat diets high in sugar and salt, which may affect long-term health. This study will test whether a MED diet can improve dietary inflammation, gut health, and body composition in toddlers and whether a tailored nutrition education program for parents can help families maintain healthy eating patterns.\n\nIn this study, toddlers will be randomly assigned to a 3-week MED diet or their usual diet. Families in the MED diet group will receive free meal boxes for the 3 weeks, plus guidance from a nutrition researcher through a structured education program. The standard diet group will continue their regular diet with general nutrition advice. Researchers will collect dietary information, body composition assessments, and stool samples to measure gut microbiome composition and metabolites.\n\nThis first study of a controlled diet intervention in toddlers, combining behavioral support, high-quality food provision, and advanced gut microbiome analysis, will help understand how early diet shapes lifelong eating habits and health, guiding public health strategies and precision nutrition approaches to prevent chronic disease from early life.",[79,80,81,82,83],"Gut Microbiome","Body Composition","Adherence","Metabolites","Inflammation",[85,86,87,83],"Dietary patterns","Gastrointestinal microbiome","Body composition","NOT_YET_RECRUITING","2026-05-11",{"date":91,"type":92},"2026-05-12","ACTUAL",{"date":94,"type":73},"2026-07-01",{"date":96,"type":73},"2027-11-01",{"name":5,"class":6},1]